Eli Lilly and partner Incyte disclosed Friday that the FDA issued a complete response letter regarding their marketing application for Olumiant (baricitinib) as a potential treatment for patients with moderate-to-severe rheumatoid arthritis. Christi Shaw, president of Lilly Bio-Medicines, stated "we remain confident in the benefit/risk" profile for the once-daily oral JAK inhibitor, adding "we will continue to work with the FDA to determine a path forward and ultimately bring [Olumiant] to patients in the US."
According to the companies, the FDA requested more clinical data to determine the most appropriate doses, as well as additional data to further characterise safety concerns across treatment arms. Eli Lilly and Incyte indicated that they disagree with the FDA's conclusions, adding that the timing of a resubmission will be based on discussions with the agency. The FDA already extended its review of the drug by three months earlier this year in order to examine data analyses that Eli Lilly had submitted in response to a request from the agency.
FirstWord reports in this therapy area: KOL Insight Rheumatoid Arthritis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more
Meanwhile, Eli Lilly reaffirmed its full-year financial guidance for 2017 and its mid-term guidance for the remainder of the decade. Incyte said it is examining the effect of the FDA decision on its previously disclosed milestone and R&D expense guidance for this year, adding that any update will be provided alongside its first-quarter financial report.
Analysts were expecting Olumiant, which garnered EU approval in February for the treatment of certain adults with moderate-to-severe active rheumatoid arthritis, to generate $1.7 billion in annual sales by 2023.
Barclays analyst Geoff Meacham suggested that Olumiant appears to have a better safety profile than Pfizer's twice-daily oral JAK inhibitor Xeljanz (tofacitinib), which was approved in the US in 2012 and in Europe earlier this year, and that Olumiant would have been preferred by doctors on an approval by the FDA. Xeljanz recorded global sales of $927 million in 2016.
For additional analysis, see ViewPoints: Pfizer secures long-sought European nod for Xeljanz; but can it compete with Eli Lilly's Olumiant? and ViewPoints: As Olumiant nears US market, Eli Lilly faces pricing conundrum.
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